Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

Tympanoplasty Surgery Clinical Trial

Official title:

The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04783233
• Other study ID #: 1685638
• Status: Withdrawn
• Start date: January 14, 2021
• Est. completion date: November 3, 2021

Study information

• Verified date: January 2022
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Little innovation in the material used for middle ear packing has occurred over the past decade, despite the fact that animal models have shown increased acute inflammation and increased fibrosis in the long term histologically. Although Chitosan Succinamide has shown improved wound healing and hemostasis in the nasal cavity mucosa, it has yet to be used as a support material, hemostatic agent, and healing agent in the middle ear. This study will utilize Chitosan Succinamide as an alternative to purified gelatin foam as a support material in primary tympanoplasty surgery.

Description:

A prospective cohort study will be performed. Healthy adults (age > 18) with single tympanic membrane perforations who have been offered and agreed to undergo tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be recruited. The surgical intervention and procedure of tympanoplasty will be performed as normal, however, the packing material will be randomly chosen using a random number generator. The middle ear and external canal will then be packed with either Chitosan Succinamide or Gelfoam. The patients in both groups will be placed on ciprodex post-operatively for 4 weeks. The patients will be seen post-operatively at 1 week for photo documentation and removal of the lateral aspect of CS/CD or Gelfoam. The patients will be seen at 4 weeks for photo documentation and the remainder of packing removal. At 3 months and 1 year the patients will have photo documentation and an audiogram.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

Inclusion Criteria:

• Healthy adults

• Single tympanic membrane perforation

Exclusion Criteria:

• Chronic recurrent infection or otorrhea

• Previous ear surgery for the study ear

• Shellfish allergy

• Cerebral Spinal Fluid (CSF) leak concern

Related Conditions & MeSH terms

• Tympanoplasty Surgery

Intervention

Biological:
• Chitosan succinamide
Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.
• Gelfoam
Gelfoam is the current packing material for tympanoplasty surgery.

Locations

Country	Name	City	State
United States	Ascension Providence Hospital Novi Campus	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dogru S, Haholu A, Gungor A, Kucukodaci Z, Cincik H, Ozdemir T, Sen H. Histologic analysis of the effects of three different support materials within rat middle ear. Otolaryngol Head Neck Surg. 2009 Feb;140(2):177-82. doi: 10.1016/j.otohns.2008.10.023. — View Citation

Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16. — View Citation

Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5. doi: 10.2500/ajra.2010.24.3422. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External auditory canal healing	Physician determines exposed bone and inflammatory response	Assess healing of auditory canal starting 1 week up to one year following surgery.
Primary	Tympanic membrane healing	Physician determines failed tympanic membrane healing and inflammatory response.	Assess healing of auditory canal starting 1 week up to one year following surgery.